Bioequivalence and Bioavailability Forum • Bioanalysis of drop out/ Withdrawal subjects for Health Canada submission

Bioanalysis of drop out/ Withdrawal subjects for Health Canada submission [Bioanalytics]

posted by Ohlbe – France, 2024-06-03 11:13 (343 d 07:36 ago) – Posting: # 24017
Views: 2,760

Dear Shreyas,

❝ What can be the consequences if drop out subjects due to personal reason or protocol non-compliance are been analyzed during bioanalytical stage.

The guidance says that you do not have to analyse them, not that you should not analyse them. They're just trying to spare you some time and money. If you have already spent them, well, too bad for you, but I don't see why they would care.

—
Regards
Ohlbe

Complete thread:

Bioanalysis of drop out/ Withdrawal subjects for Health Canada submission shreyas goswami 2024-06-01 11:13 [Bioanalytics]
- Bioanalysis of drop out/ Withdrawal subjects for Health Canada submissionOhlbe 2024-06-03 09:13
  - Bioanalysis of drop out/ Withdrawal subjects for Health Canada submission shreyas goswami 2024-06-03 17:15
    - Bioanalysis of drop out/ Withdrawal subjects for Health Canada submission qualityassurance 2024-06-04 05:25
      - All samples might be informative Helmut 2024-06-05 11:33
    - Bioanalysis of drop out/ Withdrawal subjects for Health Canada submission Ohlbe 2024-06-04 09:54
      - Bioanalysis of drop out/ Withdrawal subjects for Health Canada submission shreyas goswami 2024-06-06 20:26